The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery
Primary Purpose
Pelvic Floor Prolapse, Surgery, Pain, Postoperative
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pelvic floor injection
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Floor Prolapse
Eligibility Criteria
Inclusion Criteria:
- Female
- Able to read English and give informed consent
- Undergoing VAGINAL pelvic reconstructive surgery for POP
Exclusion Criteria:
- Hypersensitivity or allergy to amide anesthetics
Documented chronic pain condition
o (back pain, pelvic pain, fibromyalgia, etc.)
- Bleeding disorder
- Connective tissue disorder
- Neuromuscular disorder
- Cardiac conduction abnormality or channelopathy
- Hepatic Impairment
- Renal Impairment
- History of, or current, narcotic or alcohol dependence
- History of pelvic radiation or gynecologic malignancy
Sites / Locations
- Cooper Health UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bupivicaine pelvic floor muscle injection
Standard of care (no injection) preoperatively
Arm Description
Five injections at pre-specified locations at pelvic floor muscle bilaterally after induction of general anesthesia for vaginal pelvic prolapse surgery
No injection - standard analgesia
Outcomes
Primary Outcome Measures
VAS analog scale on post-op day #1
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04428320
Brief Title
The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery
Official Title
The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
May 21, 2022 (Anticipated)
Study Completion Date
May 21, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cooper Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive bilateral trans-vaginal pelvic floor muscle injections with bupivacaine or no injection (standard of care) as a part of their surgical pain control
Detailed Description
Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive:
Bilateral trans- vaginal pelvic floor levator ani muscle injections (trigger point injections) with bupivacaine:
- 0.5% bupivacaine will be injected at several sites for a total of 5ml on each side of the pelvic floor, with each injection site no more than 1 ml (Bupivacaine was chosen by the study team because of it has a longer half life then other common local anesthetics. We plan to use the same anesthetic and dosage to standardize the protocol between patients. Other local anesthetics will not be used in addition to the bupivacaine administered for research purposes. We will limit the amount of intravenous lidocaine to less than 5mg/ kg).
Control- No additional treatment (standard of care).
The patient will be blinded to their randomization (single blind). The post-operative pain regimen will be standardized when possible. Patients will receive a regimen of IV and oral narcotics and Ketorolac per our routine post-operative protocol. On discharge from the hospital, patients will be given prescriptions for a standard amount of oral narcotic, 20 tablets of oxycodone (150 morphine equivalents), and 30 tablets of 600mg ibuprofen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Prolapse, Surgery, Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bupivicaine pelvic floor muscle injection
Arm Type
Experimental
Arm Description
Five injections at pre-specified locations at pelvic floor muscle bilaterally after induction of general anesthesia for vaginal pelvic prolapse surgery
Arm Title
Standard of care (no injection) preoperatively
Arm Type
No Intervention
Arm Description
No injection - standard analgesia
Intervention Type
Procedure
Intervention Name(s)
Pelvic floor injection
Intervention Description
Injection of 10 cc of bupivacaine
Primary Outcome Measure Information:
Title
VAS analog scale on post-op day #1
Time Frame
postop day #1
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pelvic organ prolapse surgery for female genitalia
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female
Able to read English and give informed consent
Undergoing VAGINAL pelvic reconstructive surgery for POP
Exclusion Criteria:
Hypersensitivity or allergy to amide anesthetics
Documented chronic pain condition
o (back pain, pelvic pain, fibromyalgia, etc.)
Bleeding disorder
Connective tissue disorder
Neuromuscular disorder
Cardiac conduction abnormality or channelopathy
Hepatic Impairment
Renal Impairment
History of, or current, narcotic or alcohol dependence
History of pelvic radiation or gynecologic malignancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lioudmila Lipetskaia, MD
Phone
610-462-608
Email
lipetskaia-lioudmila@cooperhealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Devon Smith, MD
Email
smith-devon@cooperhealth.edu
Facility Information:
Facility Name
Cooper Health University
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lioudmila Lipetskaia
Phone
610-462-1608
Email
lipetskaia-lioudmila@cooperhealth.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No sharing planned as of now
Learn more about this trial
The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery
We'll reach out to this number within 24 hrs